510(k) K900316

MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES by Irvine Scientific — Product Code HDR

K900316 is an FDA 510(k) premarket notification submitted by Irvine Scientific for the device "MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES". The FDA issued a decision of Substantially Equivalent on April 16, 1990. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250. Irvine Scientific has at least 10 other 510(k) clearances on record.